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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT

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AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT Back to Search Results
Model Number 1002817
Device Problem Material Twisted/Bent (2981)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in (b)(6). It was reported that an (b)(6)-year-old male patient experienced high blood glucose level of 30. 9 mmol/l due to a kinked cannula as the patient did not receive insulin. This issue happened twice and for both the events, kinked cannula symptoms/ issue was noticed after three hours of insertion. The first event occurred on (b)(6) 2021 and the second event occurred on (b)(6) 2021. To treat this issue, a correction injection (multiple daily injection) was administered. Moreover, he had traces of ketones and the infusion set had been used for less than a day. The infusion set was replaced, and insulin was resumed successfully. Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length. Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly. No further information available.
 
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Brand NameAUTOSOFT 90
Type of DeviceUNO INSET II 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key12487075
MDR Text Key271867065
Report Number3003442380-2021-00482
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002817
Device Lot Number5345532
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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